CClinicalTrials.gg
Status unknownNCT03899714Updated Apr 2, 2019

Return to Physical Activity Following Injury: Towards Understanding a More Accessible Solution for Shorter Recovery Time.

An interventional study of Cryotherapy in Cryotherapy, sponsored by Cairo University. Status unknown. Open to female participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-02.

Sponsored by Cairo University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
Female
01

Study summary

The purpose of this study is to investigate the effect of cryotherapy application on hip adductors and ankle evertors on the Overall Stability Index (OSI), the Medio-Lateral Stability Index (MLSI), and the Antero-Posterior Stability Index (APSI) in healthy adult females.

Read the detailed description

Cryotherapy is one of the most common and inexpensive forms of treatment for both acute and chronic injuries. Yet, there is a deficiency in research concerning the impact of cooling on balance in healthy females

02

Conditions studied

  • Cryotherapy

Keywords

  • Postural Stability
  • Public Health
  • Balance
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy females will participate in this study. All participants should have unrestricted ankle and hip joints range of motion as well as ankle and hip muscles strength grade four to five (using manual muscle testing).

Exclusion criteria

Exclusion Criteria:

  • Participants will be excluded from the study if they had any previous history of hip or ankle joint neuromuscular or musculoskeletal injury or surgery, any pathology to the hip or ankle joints (i.e. abnormal ligament laxity and congenital deformities), any problems related to balance and stability.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Ankle evertors

    Ice packs will be applied to the selected muscles according to the random selection that will be performed previously. The ice bags will be filled with crushed ice, weighing approximately one half of a kilogram. They will be wrapped in a thin cotton towel, and applied on the skin along the anatomical location of the tested muscles. For the ankle evertors, the ice bag will be applied to the lateral side of the ankle encompassing the lateral malleolus.The cryotherapy session will be lasted for exactly 20 minutes . Sessions will be separated by a 30-minute rest interval

    Other: Cryotherapy

  • Active comparator
    Hip adductors

    Ice packs will be applied to the selected muscles according to the random selection that will be performed previously. The ice bags will be filled with crushed ice, weighing approximately one half of a kilogram. They will be wrapped in a thin cotton towel, and applied on the skin along the anatomical location of the tested muscles. For the hip adductors, the ice bag will be applied to the medial side of the thigh, covering the entire area from the groin, to just above the knee joint. The cryotherapy session will be lasted for exactly 20 minutes . Sessions will be separated by a 30-minute rest interval

    Other: Cryotherapy

Interventions

  • OtherCryotherapy

    Crushed ice in a plastic bag will be used, as it is a widely accessible and financially convenient method of cryotherapy. One half of a kilogram of ice will be placed in a plastic bag. The plastic bags will be 17 cm wide and 22 cm long. The air will be squeezed out of the bag and it will be sealed. The bag will be wrapped in a wet towel and applied to the tested area. Every five bags of crushed ice will be kept in an insulated foam container containing one kilogram of dry ice. Dry ice has a temperature of negative 80 degrees Celsius, and is used to keep the bags of crushed ice in a frozen state till the participants are briefed and the testing began.

06

What researchers measure

Primary outcomes

  1. Overall Stability Index

    The Stability Index represented the variance of platform displacement in degrees from a leveled position in both the AP and ML directions. A high number is indicative of poor neuromuscular control, which may increase the potential for orthopedic injury or falling.

    Time frame: changes from Baseline to immediately after the cryotherapy application

Secondary outcomes

  1. Medio-lateral Postural Stability Index

    Time frame: changes from Baseline to immediately after the cryotherapy application

  2. Antero-posterior Postural Stability index

    Time frame: changes from Baseline to immediately after the cryotherapy application

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Algafly AA, George KP. The effect of cryotherapy on nerve conduction velocity, pain threshold and pain tolerance. Br J Sports Med. 2007 Jun;41(6):365-9; discussion 369. doi: 10.1136/bjsm.2006.031237. Epub 2007 Jan 15. PubMed 17224445 ↗
  • Bleakley C, McDonough S, MacAuley D. The use of ice in the treatment of acute soft-tissue injury: a systematic review of randomized controlled trials. Am J Sports Med. 2004 Jan-Feb;32(1):251-61. doi: 10.1177/0363546503260757. PubMed 14754753 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03899714
Lead sponsor
Cairo University
Responsible party
Abeer Farag Hanafy (Lecturer of Biomechanics, Cairo University) — Principal investigator
First posted
Apr 2, 2019
Start date
Apr 15, 2019 (estimated)
Primary completion
May 15, 2019 (estimated)
Completion
Jun 1, 2019 (estimated)
Last update
Apr 2, 2019

Study contacts

Abeer F Hanafy, PhD
Contact
abeerfarag22@gmail.com
01063044443
Samar O Hassounah, Master
Contact
dr.samarhassounah@gmail.com
0237617691
Ayman G Matar, PhD
study director · Lecturer of Biomechanics
Nagui S Nassif, Prof.
study chair · Assistant Professor of Biomechanics
Naglaa M Elhafez, Prof.
study chair · Professor of Biomechanics
Ghada M Elhafez, Prof.
study director · Professor of Biomechanics
Sondus Hassounah, Public Health Teaching Fellow
study chair · Public Health Teaching Fellow

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion